FDA.reportPublic FDA data

Goblin Pedicle Screw System

Primary DI
00810088651373
Brand
Goblin Pedicle Screw System
Company
MEDYNUS, INC.
Model
FPR-65040
Catalog number
FPR-65040
Device description
Reduction 6.5 * 40
Published
2022-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810088651373PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810088651373008100886513738100886513730810088651373

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
119458950
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840354203654Impeace Cervical Plate SystemTP.PL.0110TP.PL.01102026-05-06
00840354203661Impeace Cervical Plate SystemTP.PL.0112TP.PL.01122026-05-06
00840354203678Impeace Cervical Plate SystemTP.PL.0114TP.PL.01142026-05-06
00840354203685Impeace Cervical Plate SystemTP.PL.0116TP.PL.01162026-05-06
00840354203692Impeace Cervical Plate SystemTP.PL.0118TP.PL.01182026-05-06
00840354203708Impeace Cervical Plate SystemTP.PL.0120TP.PL.01202026-05-06
00840354203715Impeace Cervical Plate SystemTP.PL.0122TP.PL.01222026-05-06
00840354203722Impeace Cervical Plate SystemTP.PL.0124TP.PL.01242026-05-06
00840354203739Impeace Cervical Plate SystemTP.PL.0126TP.PL.01262026-05-06
00840354203746Impeace Cervical Plate SystemTP.PL.0224TP.PL.02242026-05-06
00840354203753Impeace Cervical Plate SystemTP.PL.0226TP.PL.02262026-05-06
00840354203760Impeace Cervical Plate SystemTP.PL.0228TP.PL.02282026-05-06
00840354203777Impeace Cervical Plate SystemTP.PL.0230TP.PL.02302026-05-06
00840354203784Impeace Cervical Plate SystemTP.PL.0232TP.PL.02322026-05-06
00840354203791Impeace Cervical Plate SystemTP.PL.0234TP.PL.02342026-05-06
00840354203807Impeace Cervical Plate SystemTP.PL.0236TP.PL.02362026-05-06
00840354203814Impeace Cervical Plate SystemTP.PL.0238TP.PL.02382026-05-06
00840354203821Impeace Cervical Plate SystemTP.PL.0240TP.PL.02402026-05-06
00840354203838Impeace Cervical Plate SystemTP.PL.0242TP.PL.02422026-05-06
00840354203845Impeace Cervical Plate SystemTP.PL.0244TP.PL.02442026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700780634583Erisma®-LPCLARIANCENKB2026-05-28
06009699900008Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900503Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900817Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900831Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900848Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900855Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900862Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900879Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900886Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900893Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900909Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900916Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900923Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900930Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900947Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900954Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900961Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900978Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900985Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900992Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901005Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901012Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901029Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901036Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901043Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901050Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901067Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901074Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901081Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28